Quaregia GmbH
About
QUAREGIA supports
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CE Marking, International Product Approvals, Technical Files, Device Safety (Electrical Safety, Mechanical Safety), Risk Management, Usability Engineering, Product Lifecycles, Software- and Hardware Lifecycle Management, Requirements Engineering, Configuration and Change Management, Remediation, CAPA, Manufacturing Process Validation
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Medical Device Software: Software Safety and Cybersecurity, Artificial Intelligence, Data Protection, Software Lifecycle Process (IEC 62304), Computer System Validation (CSV), Documentation and Submission of Medical Device Software
Due Diligence Support (e.g. company take-overs, investments), Project Management
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